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List of Drug Master Files (DMF) for 20609 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Aarti Pharmalabs (1)

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01 BUDESONIDE USP (1)

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01 India (1)

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01 Active (1)

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01 Complete (1)

Looking for Drug Master Files (DMF) for 20609 of Aarti Pharmalabs Ltd

Looking for Drug Master Files (DMF) for 20609 of Aarti Pharmalabs Ltd 1

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Aarti Pharmalabs Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

They are recognized for Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

One of their notable products is BUDESONIDE USP, with a corresponding US DMF Number 20609.

Remarkably, this DMF maintains an Active status since its submission on June 13, 2007, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of April 03, 2014, and payment made on March 04, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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